FDA (Devices) recall action 79436

Medical Components, Inc dba MedComp recalled 10 products on 2018-03-28

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2018-03-28
Critical: 0
Units: 3,215

Why these products were recalled

There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–10 of 10

SevereFDA (Devices)··2018-03-28
MedComp Recalls 12F Tesio Catheter Sets Due to Connection Failure Risk
Medical Components, Inc. is recalling 385 12F Tesio Catheter Sets because connection failures may cause blood loss or air emboli.
Product
12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Distribution
34 states
SevereFDA (Devices)··2018-03-28
MedComp Repair Kit Recalled for Potential Connection Failures and Blood Loss Risk
Medical Components, Inc. is recalling 1,575 MedComp Repair Kits due to potential connection failures that could lead to blood loss or air emboli.
Product
REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Distribution
34 states
SevereFDA (Devices)··2018-03-28
MedComp Recalls 12F Tesio Catheter Sets Due to Connection Failure Risk
Medical Components, Inc. is recalling 12F Tesio Catheter Sets because connection failures may cause blood loss or air emboli.
Product
12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Distribution
34 states
SevereFDA (Devices)··2018-03-28
MedComp Recalls Catheter Repair Kits Due to Connection Failure Risk
Medical Components, Inc. is recalling 93 Catheter Repair Kits because potential connection failures could lead to blood loss or air emboli.
Product
CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Distribution
34 states
SevereFDA (Devices)··2018-03-28
MedComp Two Part Adapter Recall for Potential Connection Failures
Medical Components, Inc. is recalling 35 MedComp Two Part Adapter kits due to potential connection failures that could cause blood loss or air emboli.
Product
TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Distribution
34 states
HighFDA (Devices)··2018-03-28
MedComp Recalls Tesio Catheter Sets Due to Connection Failure Risk
Medical Components, Inc. is recalling 55 Tesio Catheter Sets because potential connection failures could lead to blood loss or air emboli.
Product
12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Distribution
34 states
SevereFDA (Devices)··2018-03-28
MedComp Recalls 12F Modified Tesio Catheter Sets Due to Connection Failures
Medical Components, Inc. is recalling 40 kits of 12F Modified Tesio Catheter Sets because connection failures could cause blood loss or air emboli.
Product
12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Distribution
34 states
SevereFDA (Devices)··2018-03-28
MedComp Repair Kit Recalled for Potential Connection Failures
Medical Components, Inc. is recalling 5 MedComp Repair Kits due to potential connection failures that could cause blood loss or air emboli.
Product
REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Distribution
34 states
HighFDA (Devices)··2018-03-28
MedComp Catheter Repair Kit Recalled for Potential Connection Failures
Medical Components, Inc. is recalling 315 Catheter Repair Kits due to potential connection failures that could cause blood loss or air emboli.
Product
CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Distribution
34 states
HighFDA (Devices)··2018-03-28
MedComp Recalls Tesio Catheter Sets Due to Connection Failure Risk
Medical Components, Inc. is recalling 712 Tesio catheter sets because connection failures could cause blood loss or air emboli.
Product
12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Distribution
34 states